Quality Assurance & the Functional Mobility Assessment

The industry knows Complex Rehab Technology improves lives. Proving it does has been decades in the making

Jun 01, 2018

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You’re probably already familiar with the Functional Mobility Assessment (FMA). It’s a 10-question survey that asks adults to compare their activities and abilities before and after they started using a new wheelchair. Among the questions are how often they leave their homes, how well they perform transfers, how efficiently they can reach for items, and how effectively their wheelchairs meet their comfort needs.

Participants respond to the questions using scores on a scale of 1 (Completely Disagree) to 6 (Completely Agree), and they’re asked these questions repeatedly over time — because satisfaction with a wheelchair can change.

Those are the questions in the survey itself. But among the critical industry questions behind the survey is whether consumer satisfaction is impacted by the involvement of an Assistive Technology Professional (ATP) in the equipment provision process.

U.S. Rehab, a division of The VGM Group, has worldwide rights from the University of Pittsburgh “to commercialize and collect data with the FMA,” said U.S. Rehab President Greg Packer.

For years, he has been working with Pittsburgh’s Mark Schmeler, Ph.D., OTR/L, ATP, Associate Professor, Department of Rehabilitation Science & Technology. Schmeler is one of the developers of the FMA and started on the project just a few years after he began working as a clinician.

“It really is almost a 30-year process,” he said, as Pittsburgh announced it would be publishing a paper on FMA outcomes in 2018.

The Role of Big Data

To understand the need for the FMA and the data that comes from it, you need only to look at the current landscape of “big data” and the decisions it influences.

“Everything in healthcare, everything in life, everything we buy, everything we do has a metric associated with it,” Schmeler pointed out. “I think that’s becoming even more obvious now: Every time you buy something, or have a conversation with a customer service representative on the phone, or you get out of an Uber or you leave a restaurant, they ask you to rate them.”

That expectation is common in healthcare: “When you look at medicine, there’s plenty of data that tells you the drug or pharmaceutical intervention for which people under what circumstances. You’re able to have conversations with your clinicians, practitioners, people who are serving you about ‘What do you think is going to be the best treatment for me?’ And usually, they’ll say, ‘Studies show that for people in your situation, these are the chances of this outcome versus that outcome.’ That’s been around forever, but it’s really coming to light now.”

What does that mean for complex rehab technology (CRT)?

“We know what we do works,” Schmeler said. “We see it every day. We know we’re good at it. Nobody’s really in this for self promotion; we’re all here to help people with disabilities.”

But a turning point for the home medical equipment industry came in 2003. During that year’s Operation Wheeler Dealer, Medicare began scrutinizing widespread and fraudulent provisions of scooters and consumer power chairs for patients who didn’t always need them.

The result was closer scrutiny of CRT, as well.

“Unfortunately, we had an awful situation 10 years ago or so, with companies just ripping off Medicare,” Schmeler said. “If you’re the government, it’s ‘How do we stop this freight train? Sure, there are people who really need [CRT], but in the big scheme — they have no outcomes. They have limited evidence. They have little proof, nothing that shows on a large scale that [CRT] really works.”

A New Necessity

The FMA isn’t the industry’s only effort to measure the outcomes of CRT.

“There are studies out there that have been published,” Schmeler said. “We’ve had research. Sample sizes of some are fairly good. Some are small; some are mostly case studies, anecdotal.

“We talk till we’re blue in the face that a custom-fitted titanium ultralightweight wheelchair is really the best thing for a person with these conditions, and we think that everybody should just believe us. That’s what’s behind all of this. This is a necessity, and when money is short and policy makers have to make decisions about what to cover and what not to cover, there’s an unwritten formula that they use: ‘What are the political ramifications against this group of people that we might be cutting? We have to decide if we’re going to cut funding for wheelchairs or funding for cancer. Which of these two groups has better research to show that what they do works?’”

In that scenario, Schmeler said, CRT comes up short.

“We have two strikes against us. What are the political ramifications if you cut funding for people with disabilities? Well, it’s slim to none because this is a historically disempowered group of people: They are less likely to vote, be employed, or have money to lobby. And the people who serve them have limited research capabilities to support that what they do actually helps. If you look at some other area of healthcare, like women’s health — 50 percent of the population is female, they are employed, they do vote, and there is research to support treatment A vs. treatment B.

“That’s just reality, that’s how society functions.”

Creating the FMA

Trying to measure the outcomes of an industry — particularly one that hasn’t been measured before on a large scale — is a formidable task. There were challenges just in figuring out what could and should be measured first.

“I had to put some parameters around it and ask how much do we want to bite off here,” Schmeler said. “I decided the best way to get large data was to have a questionnaire focused primarily on adults and focused on adults who can self report accurately.” While the first sets of scores were provided solely by adults aged 18 and over, a “family-centered” version of the FMA is now available for children, as well as “anyone who could not accurately self-report their satisfaction for a myriad of reasons,” Schmeler said. He pointed out that some older children are capable of using the standard FMA, so deciding which of the two versions is better for a particular client will be left to the clinician.

The FMA is just 10 questions long, but formulating those questions was a years-long process.

“Many years were spent measuring the accuracy of the tool,” Schmeler said. “In science, you can’t just make up a questionnaire. It has to go through a whole systematic — what we call clinimetric — assessment. We have to look at all the psychometrics of the tool, so that we know we’re 80 percent certain that what [respondents] are saying is reality. And this tool’s gone through that.

“We know results we’re getting from the people, self reporting, are between 85 and 90 percent accurate. So we’re above the threshold.”

Among the questions the survey asks is the participant’s diagnosis (see chart).

Primary Diagnosis

Total (n=1181)

Stroke/CVA

17.53%

Other Neuromuscular or Congenital Disease

14.90%

Cerebral Palsy

9.91%

Multiple Sclerosis

9.74%

SCI (Paraplegia)

8.55%

SCI (Tetraplegia/Quadriplegia)

5.93%

Osteoarthritis

4.49%

Amputation

3.64%

Morbid Obesity

3.39%

Spina Bifida

2.88%

An equal distribution of males and females represents a sample of the population. The average age of the sample is 59 years (SD = 17). Age was normally distributed with a skewness of 0.43 (SE=0.07) and kurtosis of 0.45 (SE=0.14). A breakdown of the top 10 diagnoses represents the most common diagnoses within the sample. Courtesy U.S. Rehab and the University of Pittsburgh.

“There are about 40 diagnostic categories in our data set that you can pick from,” Schmeler said. “We decided just to report on the top 10. You can see here that spina bifida is 2.88 percent. Once we started getting below that, we were talking about 1 to 2 percent of the population. We have close to 1,200 cases now. As we’re getting more data, this top 10 is not changing anymore. We know we’ve hit saturation on diagnosis. We’re 99 percent sure that the majority of people who need complex rehab have a stroke, followed by neuromuscular disease, followed by cerebral palsy, followed by multiple sclerosis.

“This is helpful, because when we go to Congress or policy makers, and they say, ‘You guys are those wheelchair people selling scooters,’ I say no — close to 80 percent of the people we are serving have strokes, neuromuscular diseases, spinal cord injury, and cerebral palsy. Here are our numbers. You’ll see in there osteoarthritis is just shy of 5 percent, but this is a neuromuscular group.”

Not Research…Yet

Schmeler emphasized that these numbers can’t be categorized as research.

“This report is not yet research,” he said. “This is quality-assurance work. VGM has members who are businesses, and they need quality-assurance metrics to be certified, just like Uber drivers need a rating. Quality-assurance metrics are part of society and part of what we do.

“What industries then do is take everybody’s data, aggregate it, and send it to a university or a company like the RAND Corp. to do scientific analysis. That’s research. Right now, the research is being done, but this is just quality assurance.”

Also on the “what’s next” task list is getting more CRT professionals to collect and share their information.

“Greg and I are really trying to motivate people to give us data,” Schmeler said. “If we can start sharing some of these quality-assurance outcomes — when we’re working with suppliers and clinicians, my experience has been that they don’t want to measure outcomes. It’s a chore, like having to make your bed in the morning. But once you start to see the value of these graphs, that really is motivating. Like Wow, I really do good work. I want to know more now. I want you to analyze this versus that. Well, we need larger data to do that.”

U.S. Rehab members have supplied data for years, and participating providers receive quarterly reports of their data. Packer said the data is “de-identified,” with client and provider names removed before the University of Pittsburgh receives it to analyze. FMA scores are then used to determine which clients need closer follow-up.

“We contact the patient, on average, five times in the first year,” Packer said. “We also have a mechanism in place that if their score drops by a certain percentage, we’re contacting the clinician as well as the provider to reassess the issue. We make sure there has been patient contact by the provider to make an equipment adjustment or to change out a cushion or whatever needs to be taken care of. Once that’s done, we put [the client] back into the system for the next call.”

If the client’s FMA score increases the next time, then that client is considered back on track. But if a client has issues three times within the first year of having his or her wheelchair, “we’re going to contact them more frequently in the second year than we would for a patient whose FMA scores have all been fine.”

“This is also different from a research study in that this is a business model,” Schmeler said. “It’s modeled after the Functional Independence Measure, which is another tool that’s used in rehab — not rehab tech, but in regular rehabilitation, where all patients get a Functional Independence Measure score at different periods of time through their rehab treatment.”

He compared the FMA to another common healthcare device that measures.

“Think of this tool as a bathroom scale,” he said. “That’s all it is. It’s telling you how much you weigh. You can weigh yourself every day, you can put yourself on a diet and weigh yourself again. And that’s all this is doing.”

In Mobility Management July: More FMA results, including the impact an ATP can have on client success and steps to get started. For more info on the FMA, go to www.FMA.USRehab.com or contact Mark Schmeler at schmeler@pitt.edu or Greg Packer at greg.packer@usrehab.com.

This article originally appeared in the June 2018 issue of Mobility Management.